BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE COLLAMER LENS (ICL)

    MDR report key: 8678998 · Received June 7, 2019

    Report

    Report Number
    2023826-2019-01026
    Event Type
    Injury
    Date Received
    June 7, 2019
    Report Date
    May 13, 2019
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE - UNK. SEX - UNK. WEIGHT - UNK. ETHNICITY - UNK. RACE- UNK. EVENT DATE - UNK. LOT#, SERIAL# - UNK. IMPLANT DATE - UNK. PMA/510K- UNK. (B)(4). MANUFACTURE DATE - UNK. CLAIM# (B)(4).

    Description of Event or Problem · 1

    AN ARTICLE WAS PUBLISHED IN THE JOURNAL OF ADVANCES IN MEDICINE AND MEDICAL RESEARCH IN MARCH 2019 TITLED, 'TORIC AND PHAKIC IOLS FOR THE TREATMENT OF ASTIGMATISM AND/OR HIGH MYOPIA: OUR EXPERIENCE AT PRINCE HASHEM HOSPITAL ZARQA.' THE ARTICLE STATES THAT 3 PATIENTS WHO RECEIVED VISIAN ICL'S HAD LENS ROTATION AFTER SURGERY AND THIS WAS DUE TO UNDERSIZING OF THE LENS. THEY UNDERWENT LENS EXCHANGE AND REPLACED WITH A LARGER ICL WITH MORE STABLE ALIGNMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE HAS BEEN FORTHCOMING. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471817 IMPLANTABLE COLLAMER LENS (ICL) PHAKIC INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention